1. Field of the Invention
The present invention relates to fluid collection pouches or bags for use in surgical procedures to collect, channel and contain fluids from a surgical site during an operation, and more specifically to pouches such as arthroscopic fluid collection pouches and to pouch and drape assemblies. The invention also relates to methods of making such pouches and such pouch and drape assemblies.
2. Related Art
During many surgical procedures, it is frequently desirable to create a sterile field around a surgical site to reduce the possibility of infection of a patient. Typically, a sterile field is created by draping a sterile material over a patient in such a manner as to leave an opening only at the actual site of an incision. Such surgical drapes have been used for many years. Originally, the focus of draping was to protect the patient from infection. Recently, that focus has expanded to include protection of the surgical staff from infection. Examples of the types of infection that a staff member may be exposed to from fluids include the hepatitis B virus and the AIDS virus. Thus, another function of surgical drapes used today is to provide a barrier to the exposure of liquids or bacteria which may result in contamination of the patient or the staff performing the surgical procedure.
In some surgical procedures very large volumes of fluid may be present either from irrigation sources or from the patient's body fluids. It is desirable in most instances to control and contain such fluids. Some drapes have been used in the past which contain a pouch to collect fluids present during surgery. Collection of the fluids in the pouch also facilitates disposal of the fluids after the surgery.
Fluid collection pouches are commonly used in a number of surgical procedures. Cranial procedures, endourological operations, ophthalmic procedures and arthroscopic surgery use fluid collection pouches to collect, contain and facilitate disposal of fluids produced during the procedure. In arthroscopic surgery, patient blood, other body fluids, as well as irrigation fluid used to flush material from the joint, is collected in the fluid collection pouch.
Fluid collection during arthroscopic procedures is different in some respects from fluid collection during other surgical procedures. For example, using a collection pouch to collect and contain fluid during abdominal surgery has the fluid collection pouch placed adjacent one side of the surgical site and extending down the side of the patient. Arthroscopy procedures typically place a patient's leg through a collection pouch mounted to a drape with one sheet of the collection pouch in front of the surgical site on the limb and another sheet of the collection pouch in back of the surgical site. Therefore, the fluid collection pouch is supported in part by the limb itself, as well as by the surgical drape to which the fluid collection pouch is attached.
One disadvantage of the currently available disposable collection pouches is that they are formed of separate sheets sealed together, and may leak. Leaks may form at any number of seals in the pouch when the pouch is pulled outward or is opened before the procedure for collecting fluids. As many as five seals may be used in the construction of a single bag, each of which may present a risk of leakage in the pouch.
A relatively large number of seals used in assembling a fluid collection pouch uses significant labor and assembly time. Depending on the complexity of a collection pouch design, the location and the positioning of the seal lines may substantially add to handling time. This additional time and labor represents a significant increase in the cost of production for disposable fluid collection bags.
Another disadvantage of prior fluid collection pouches is that they are relatively complicated to manufacture in that they require the joining of multiple sheets to form a pouch that is conformable to the body of a patient to control fluids. For certain applications, the collection pouch pattern may be more complicated in order to control fluids released at a particular surgical site, such as the arm or leg of a patient. Substantial labor steps may be necessary for forming odd-shaped patterns, or for joining multiple sheets of material into a pattern for a pouch specifically constructed for controlling fluids during surgery, such as an arthroscopic procedure.
Another disadvantage of some fluid collection bags, particularly for use during surgical procedures on a patient's leg, is that the collection pouch may not extend forward and away from the patient far enough to adequately expose a surgical site, and it may not provide an opening large enough for capturing fluids. The opening in a conventional fluid pouch, for example, may be symmetrical and relatively simple to manufacture and pack. However, a symmetrical opening in a fluid pouch may not adequately control fluid at an irregularly-shaped area of a body, such as the leg of a patient.
Some conventional collection pouches having extended portions to control fluids during a surgical procedure formed of multiple sheets of flexible plastic that require multiple seals and multiple sealing steps. One disadvantage of these pouches is that they require separate sheets of plastic and a significant number of seals. The increased number of seals in a collection bag generally increases the risk of fluid leakage and the spread of infection, in addition to an added cost of assembly.
Therefore, there is a need for a fluid collection pouch and for a pouch and surgical drape assembly which minimizes the possibility of leaks developing during use, such as at seal points, and which is easier to assemble and use.